TW201526933A - Tracheal tube system including tracheal tube and suction device - Google Patents

Abstract

Tracheal tube systems may include first and second tubes and an inflatable balloon. The first tube may be flexible and hollow and have first and second open ends. The inflatable balloon may be affixed to and circumferentially surround a portion of the first tube. The inflatable balloon may include an indentation sized and positioned to accommodate a portion of a second tube positioned therein, when the inflatable balloon is inflated. The second tube may be hollow and have a multiplicity of holes along a sidewall not in contact with the balloon. The second tube may be configured to be coupled to a suction device that creates a negative pressure in the second tube. When the tracheal tube system is inserted in a patient's trachea, the negative pressure in the second tube may act to remove, or suction out, fluids and other matter from the trachea.

Description

Tracheal catheter system including an endotracheal tube and a suction device

This application is part of a continuation of U.S. Patent Application Serial No. 14/149,403, filed on Jan. 7, 2014, which is incorporated herein by reference. A contiguous section of U.S. Patent Application Serial No. 14/051,443, the entire disclosure of which is incorporated herein by reference.

This specification is generally in the field of endotracheal tubes and suction devices.

The subject matter discussed in the background section should not be assumed to be prior art, only as it is mentioned in the background section. Similarly, the problems mentioned in the background section or associated with the subject matter in the background section and the understanding of the cause of the problem should not be assumed to have been previously recognized in the prior art. The subject matter in the background section may only represent different methods, and the invention itself may also be an invention.

Endotracheal tubes that utilize aspiration tools and have an inflated balloon are widely known in the prior art. However, such prior art aspiration tools are incapable of aspirating secretions on and around the balloon, while allowing secretions and/or pathogens to pass through the balloon and tracheal wall and into the airflow of the tracheal tube. In some cases, the secretion/pathogen is atomized through the high velocity ventilation air of the endotracheal tube and into the patient's lungs. Atomized pathogens that move at high speeds may transmit pathogens deep into the lungs, which may cause Ventilator Associated Pneumonia.

The tracheal catheter system can include first and second catheters and an inflatable balloon. The first conduit can be flexible and hollow and has first and second open ends. The inflatable balloon can be attached to a portion of the first conduit and circumferentially surround a portion of the first conduit. A first end of the first conduit is configured to be coupled to the manual extraction device and the first conduit, and can be configured to allow air or other gas provided by the manual extraction device to flow through the first conduit into the cannula (with an endotracheal tube) System) in the patient's lungs.

When the inflatable balloon is inflated, the inflatable balloon can be positioned between the first end and the second end of the first catheter and include a recess of a particular size and location to receive a portion of the second conduit positioned therein. In some embodiments, the recess can extend around a circumference or a portion of the circumference of the inflatable balloon.

In some embodiments, a portion of the recess is located at or near the point of convergence of the inflatable balloon, with a connection point between the inflatable balloon and the first conduit. The connection point can be between the first end of the catheter and the balloon.

The second conduit can be hollow and have a plurality of holes along the sidewall that is not in contact with the balloon. In some examples, the second conduit can be curved or pre-configured into a particular shape (eg, triangular, circular, etc.). The second conduit can be flexible, rigid, or some combination of the two. In some cases, the second conduit can be an assembly of two or more components. The second catheter can be attached to the balloon by a concave, for example, a chemical- or heat-generated bond, a sleeve, a strap, and/or a clamp.

The second conduit can be configured to be coupled to a suction device that creates a negative pressure in the second conduit. In some cases, the first conduit can have a lumen coupled to the suction device and a negative pressure in the lumen can result in a negative pressure in the second conduit. When the endotracheal tube system is inserted into the patient's trachea, the negative pressure in the second catheter can remove or draw fluid and other substances from the trachea. In some cases, when the endotracheal tube system is placed in the trachea, the negative pressure generated by the suction device can act to hold the inner or inner wall of the trachea to hold the second catheter, thereby preventing secretions from moving beyond the ball. The capsule enters the lower trachea or the lungs.

In some embodiments, the recessed and second catheter can be positioned relative to the inflatable balloon such that when the endotracheal tube system is inserted into the trachea, the balloon is inflated and the negative pressure is applied to the second catheter by the suction device, The second catheter will be positioned against a portion of the tracheal wall, such as the posterior portion of the tracheal wall.

While various embodiments of the invention may be devised by various disadvantages of the prior art, which may be discussed or referred to in one or more places in the specification, the embodiments of the invention do not necessarily address any of these disadvantages. In other words, different embodiments of the present invention can address the different deficiencies that may be discussed in this specification. Some embodiments may only partially address some of the deficiencies or only one deficiencies discussed in this specification, and some embodiments may not address any of these deficiencies.

In general, the discussion of each of the figures in Figures 1 through 5 begins with a brief description of each element, which may have no more than one of the figures of Figures 1 through 5 discussed. The name of the component. After a brief description of each component, the various components are discussed further in numerical order. In general, each of the figures in Figures 1 through 5 is discussed in numerical order and the elements in Figures 1 through 5 are also generally discussed in numerical order to facilitate the positioning of the discussion of the particular elements. However, there is no position where all information of any of the components of Figures 1 - 5 must be located. The sole information about any particular element or any other aspect of any of Figures 1 through 5 can be found in any part of this specification or as indicated by any part of this specification.

FIG. 1 shows an illustration of an embodiment of an endotracheal tube system 100. The tracheal tube system 100 can include at least one connector 102, a catheter 106 having opposing open proximal ends 104 and an open distal end 122, a suction device 108A, a gas distribution device 108B, a fluid dispensing device 108C, a fluid reservoir 108D, at least one Suction catheter 108E, at least one inflation catheter 110A, guiding balloon 110B, inflation fluid supply 110C, at least one aspiration catheter lumen 112, at least one inflation catheter lumen 114, at least one suction lumen outlet 116, at least one The balloon 118, at least one suction line 120, at least one amplification opening 124, and at least one amplification air passage 126. In other embodiments, the endotracheal tube system 100 may not have all of the listed elements or features and/or may have other elements or features in addition to or in addition to those listed. For example, the balloon 118 can be closed at both ends (that is, a portion of the balloon 118 closest to the open distal end 122 can be closed to seal the enlarged air passage 126.

The endotracheal tube system 100 is a tracheal tube having a 360 degree aspiration line and an amplifying air flow path. In the examples, the suction was set to a negative pressure of 15 mmHg. The endotracheal tube system 100 can be adapted for use with different catheters, such as endotracheal tubes, endobronchial tubes, and tracheostomy tubes. The endotracheal tube system 100 is a catheter that is inserted into the trachea through the mouth or nose to maintain an open air passage or to deliver oxygen, drugs, or to allow suction of mucus or to prevent secretions from being inhaled into the mouth. The endotracheal tube system 100 can be a flexible hollow cylindrical catheter that is open at both ends to allow air to pass therethrough.

Connector 102 is a connector suitable for attachment to a mechanical respirator. The connector 102 attaches the endotracheal tube system 100 to a mechanical respirator. In an embodiment, the connector 102 can have a length of 4 cm, a proximal outer diameter (OD) of 1.5 cm, a proximal inner diameter (ID) of 1.3 cm, and a proximal length of 1.5 cm. The cross-sectional area of safety (which is a collar) is 1.5 cm x 2.5 cm. In the examples, the length of the safety is 0.5 cm. In an embodiment, the distal opening outer diameter (OD) of the connector 102 is 0.8 cm. In an embodiment, the distal end of the connector 102 is 2 cm in length. In the examples, the tolerances for all of the dimensions listed in this specification are +/- 10% of the dimensional values discussed. In another embodiment, the tolerances in this specification are +/- 5% of the dimensions in question. In an embodiment, the connector 102 is fabricated from a rigid polypropylene. In other embodiments, mechanical respirators may be replaced by air bags if mechanical respirators are not available.

The proximal end 104 is one end of an endotracheal tube system that is not cannulated into the patient. In this specification, a patient cannula is shown in the patient to place a catheter. For example, intubating a patient can mean inserting a breathing catheter into the trachea for mechanical breathing. The proximal end 104 is open and connected to one end of the connector 102 relative to the mechanical respirator. In an embodiment, the proximal end 104 has a length of 31 cm. In an embodiment, the proximal end 104 is fabricated from flexible polyvinyl chloride.

Catheter 106 is a catheter that is inserted into the body to aid in the delivery of medication. The catheter 106 can be inserted into the trachea to deliver oxygen. The conduit 106 can be made from a tube. The conduit 106 can be made of plastic (eg, polyvinyl chloride, PVC). The plastic material can be visually transparent or opaque. Since the plastic is not radioactively opaque, the catheter 106 can have a line of radioactive opaque material that makes the catheter more visible on the chest X-ray. In other embodiments, the conduit 106 can be made of wire-reinforced silicone rubbers. In still other embodiments, the conduit 106 can be made of silicone rubber, latex rubber or stainless steel. The different materials used to make the endotracheal tube are typically based on the desired catheter application. For example, a wire-reinforced silicone rubber catheter is quite flexible and difficult to compress or kink, allowing a wire-reinforced silicone rubber catheter to facilitate intubation during which the trachea is expected to remain for a prolonged period of time, or if the neck needs to remain active during surgery Sexual situation.

The conduit 106 can have an inner diameter and an outer diameter. The "size" of the endotracheal tube indicates the inner diameter of the catheter. For example, if a "size 6" endotracheal tube is required, then an endotracheal tube with a 6 mm inner diameter is required. Further, the inner diameter of the catheter 106 can be indicated as "ID6.0". A narrower conduit adds resistance to the airflow. For example, a 4 mm-sized catheter has 16 times greater resistance to airflow than a 8 mm-sized catheter. Additional resistance can be particularly relevant to spontaneously breathing patients who will need to work harder to overcome the increased resistance. Therefore, when choosing the appropriate "size", the maximum size for a given patient is usually recommended. For humans, the size of the catheter 106 can range from 2.0 mm for newborns to 10.5 mm for adult males. Catheter 106 can have an OD of 0.7 cm to 0.9 cm (based on the size of the patient).

The catheter 106 can have a varying length based on who or what uses the catheter 106. The length of the conduit 106 is measured from the end that enters the trachea. If the catheter 106 is inserted through the mouth or through the tracheostomy, the length of the catheter can vary. For a person who is orally inserted, the length of the catheter 106 can range from 7.5 cm for newborns to 23 cm for adult males. In an embodiment, the catheter 106 can be inserted orally or nasally as an endotracheal tube.

In another embodiment, the catheter 106 can be inserted into the tracheostomy stomata and used in the tracheostomy. The tracheostomy is the opening through the neck into the trachea through which the catheter can be inserted to maintain an effective airway and assist the patient in breathing. The tracheostomy stomata are true openings. When the catheter is used in a tracheostomy, the length of the catheter 106 can be shorter.

107 is a main channel for passing the oxygen containing gas to the patient or a conduit for the main channel of the carbon dioxide withdrawn from the patient (CO ₂₎ 106. The OD of the main channel 107 is a variable of 0.6 cm to 0.8 cm. In the embodiment, the diameter of the main passage 107 is the same as the inner diameter of the conduit 106.

Suction device 108A is a machine that can be used to remove mucus and other undesired fluids from a patient. Suction device 108A creates a negative pressure to draw mucus and other undesired fluids from the patient. The suction device 108A can have a varying power of suction. Suction device 108A can be operated continuously with low power set by suction to provide constant suction. Suction device 108A can operate periodically or on a desired basis based on the application.

Gas distribution device 108B is a machine that can be used to draw air or other gases as well as aerosols (eg, drugs). The gas distribution device 108B can be an electronically driven gas distributor, or a manual air pump such as an air filled syringe.

Fluid dispensing device 108C is a machine for aspirating fluid. The fluid dispensing device 108C can be an electronically driven fluid dispenser having varying or fixed distribution of power. The fluid dispensing device 108C can also be a manual operating device such as a fluid filled syringe.

The fluid reservoir 108D is a reservoir for storing the cleaning fluid for dispensing into the patient to help loosen the accumulated mucus to allow for easier withdrawal. The fluid reservoir may be clean water used as a cleaning agent and/or may contain another cleaning agent, or may be a saline or antibiotic rinsing agent. Fluid reservoir 108D can be a fluid source for fluid dispensing device 108C. In some embodiments, fluid dispensing device 108C may not need to be withdrawn from fluid reservoir 108D.

Suction catheter 108E is a catheter adapted to aspirate balloon boundaries and secretions collected within the tracheal region surrounding the endotracheal tube. The boundary of the balloon and the tracheal region are the cavity portions of the throat below the true vocal cords. The aspiration catheter 108E can be adapted to be coupled to a suction device to aspirate secretions. In some embodiments, the aspiration catheter 108E can be attached to the catheter 106 near the open proximal end 104. In other embodiments, the aspiration catheter 108E can extend into the inner wall of the catheter 106. The length of the suction catheter 108E is 24 cm. The suction conduit 108E can be made of flexible polyvinyl chloride.

In another embodiment, the aspiration catheter 108E can be adapted to be coupled to the gas distribution device 108B to dispense gas into the aspiration catheter 108E to empty the aspiration catheter.

In yet another embodiment, the aspiration catheter 108E can be adapted to be coupled to the fluid dispensing device 108C to provide a fluid for cleaning. The fluid dispensing device can draw irrigation fluid from the fluid reservoir 108D. The action of the irrigation fluid can release secretions and mucus surrounding the balloon boundary and the tracheal region surrounding the trachea to release mucus that can be collected around the endotracheal tube. Once the irrigation fluid is introduced, the aspiration catheter 108E can resume suction, while the liquid and any secretions that may have been loosened or dissolved can be removed. The introduction of the flushing fluid can be considered as necessary and repeated and performed at the discretion of the caregiver or user to cleanse secretions and other fluids that may accumulate and potentially block suction. The rinsing fluid can comprise water, saline, and other biocompatible liquids or mucolytic agents. Mucolytic agents are agents that dissolve thick mucus and are commonly used to help relieve dyspnea. This is achieved by dissolving various chemical bonds in the secretions and thereby reducing the viscosity by changing the components containing mucin.

The inflation catheter 110A is a catheter for providing an inflation fluid. In an embodiment, the inflation catheter 110A has a length of 24 cm. In an embodiment, the inflation catheter is made of flexible polyvinyl chloride.

The guiding balloon 110B is a balloon that provides an indication of the air pressure present in another balloon to which it is attached. In addition, the guide balloon 110B has a one-way valve that vents air that is inflated into the guide balloon 110B due to its one-way valve design. When the guide balloon 110B is squeezed, the guide balloon 110B can function as a balloon deflator, thus converting the one-way valve into a two-way valve.

The inflation fluid supply device 110C is a device that delivers inflation fluid. The inflation catheter 110A can be coupled to the inflation fluid supply device 110C via the guide balloon 110B. The fluid supply device 110C can be a syringe or a pump. The inflation fluid can be a gas or a liquid based on the desired functionality of the aeration fluid. The inflation fluid can be air. The aerated fluid may also be a methylethylene blue colored saline. For example, some airway procedures involve the use of a laser beam to burn tissue. Such a beam of light may ignite a common endotracheal tube and may cause a major airway to burn in the presence of oxygen. If the laser causes damage to the balloon, color development will help identify the rupture and the salt water will help prevent airway burning.

The aspiration catheter lumen 112 is an extension of the aspiration catheter 108E that extends along the length of the catheter 106. The aspiration catheter lumen 112 further provides suction from the aspiration catheter 108E to the endotracheal tube. The aspiration catheter lumen 112 can be coupled to the aspiration catheter 108E or it can be an extension of the aspiration catheter 108E that is coupled to the catheter 106. The aspiration catheter lumen 112 can also extend along the length and inside the wall of the catheter 106. In another embodiment, the aspiration catheter lumen 112 can be attached to the outer surface of the catheter 106 and extend along the length of the catheter 106. In other embodiments, the aspiration catheter lumen 112 can provide irrigation fluid from the aspiration catheter 108E.

The inflation catheter lumen 114 is an extension of the inflation catheter 110A that extends along the length of the catheter 106. The inflation catheter lumen 114 can be coupled to the inflation catheter 110A. The inflation catheter lumen 114 can also be an extension of the inflation catheter 110A that extends along the length and inside the tube wall of the catheter 106. In another embodiment, the inflation catheter lumen 114 can be attached to the outer surface of the catheter 106 and extend along the length of the catheter 106.

The suction lumen outlet 116 is the point in which the inflation catheter lumen 114 is presented from the catheter 106. The suction lumen outlet 116 is strategically positioned along the length of the catheter 106 such that it is proximate to the location where the secretion is accumulated in the region of the balloon adjacent the balloon and trachea.

The balloon 118 is an inflatable resilient cuff. The balloon 118 acts as a seal between the endotracheal tube and the patient's tracheal wall to allow positive pressure ventilation. Positive pressure ventilation is a mechanical ventilation in which air is normally delivered to the airway and lungs under a positive pressure through the endotracheal tube, and a positive airway pressure is generated during inhalation. The balloon 118 can be made of various components of rubber or elastomeric polymeric polyurethane. Based on the intended use of the balloon 118/tracheal catheter system 100, the thickness and elasticity of the rubber material can vary. In the embodiment, the balloon 118 is 5 cm long and 3 cm in diameter. Excluding rare errors in calcium metabolism, the tracheal diameters of most human males and females fall within the range of 25-29 mm and 23-27 mm, respectively. In an embodiment, the seal between each chamber is incomplete such that air is allowed to flow from one balloon to the next (the opening between the chambers may be the width of the balloon and between 0.1 and 0.5 High between cm). In some embodiments, the balloon 118 can be a high pressure, low volume balloon. In other embodiments, the balloon 118 can be a low pressure, high volume balloon. Suitable materials will be used based on the intended purpose and use of the balloon. When introduced into a patient, the balloon 118 is initially deflated. Once the endotracheal tube system 100 is placed in the trachea within the patient, the inflation catheter 110A can be adapted to the fluid supply device to inflate the balloon 118. The balloon 118 is coupled to the inflation catheter lumen 114. Once the balloon 118 is inflated, the shape and expanded size of the balloon 118 creates a seal against the wall of the trachea, thereby preventing gas that is pumped into the lungs via the catheter 106 from backing up and passing through the catheter. The tracheal tube leaks out to provide positive pressure ventilation. The inflation of the balloon 118 creates a seal to provide the necessary positive pressure for the lung to assist the breathing manually.

The balloon 118 is attached to a catheter 106 between the suction lumen outlet 116 and the distal end 122. The balloon 118 completely seals the catheter 106 at one end of the balloon that is offset from the suction lumen outlet 116. However, the opposite ends of the balloon 118 do not seal the conduit 106. Instead, the balloon 118 near the open distal end 122 has a cylindrical shape. When the balloon is not attached to the endotracheal tube, it will resemble the shape of the bottle that lacks the bottom of the bottle. The shape of the balloon is created by the circular chamber of the balloon and the size of the chamber can be varied, first the largest balloon and the size of the balloon decreases in the direction towards the lungs. For example, in an embodiment, the diameter of the balloon 118 of the chamber, sequentially from the proximal end to the distal end, is 3 cm, 1 cm, 0.6 cm, 0.4 cm, 0.2 cm, and 0.1 cm, respectively.

In another embodiment, the balloon 118 can extend from the open distal end 122 along the length of the catheter 106 and end near the connector 102.

An endotracheal tube with a balloon 118 may present a problem in which secretions generated above the balloon 118 may be prevented from flowing along the passage of the esophagus or trachea and thereby accumulating above the balloon 118, which provides a location where pathogens may accumulate. Sometimes, these pathogens may find a path through the balloon created by the balloon 118 and the result will be below the balloon near the open distal end 122. Once the pathogen passes through the balloon 118, the pathogen can find a path into the patient's lungs and produce a harmful infection. Secretions accumulated above the balloon 118 may also present other problems.

Suction line 120 is a conduit having small holes distributed along the sidewalls of the conduit. It is important to note that the holes pass only through one side wall of the suction line 120, relative to the two side walls that pass through the suction line 120. The holes may be distributed in any suitable arrangement and may be arranged, for example, in a cluster or evenly distributed manner. The sidewalls of the holes may be formed into any suitable shape, such as a V-shaped, U-shaped or square shape. The opening formed by the aperture in the suction line 120 can be any suitable shape, such as, but not limited to, circular, elliptical, square, rectangular, or any combination thereof. In an embodiment, the suction line 120 has a length of 1 cm. The small holes allow for the aspiration and removal of secretion fluid in contact with the aspiration line 120. The aspiration line 120 can be an extension of the aspiration catheter 108E and the aspiration catheter lumen 112. Aspiration line 120 emerges from the wall of the catheter 106 at the suction lumen outlet 116. The point of attachment between the balloon 118 and the catheter 106 proximate to the aspiration line 120 can be located 0.5 cm-1.5 cm above the balloon 118 to ensure that the balloon 118 is securely sealed to the catheter 106. Suction line 120 is wrapped around catheter 106 and over balloon 118. The coating of the aspiration line 120 is provided in the upper space of the balloon 118 and in the patient's trachea at the level of the balloon aspiration line attached to the balloon that does not negatively affect the patient's breathing (by the balloon and A 360 degree aspiration of the accumulated secretion fluid in the area bordered by the trachea.

Suction line 120 can also be wrapped around balloon 118. The aspiration line 120 can wrap the balloon 118 multiple times before the distal end point of the outer surface of the balloon 118 terminates. Suction line 120 provides aspiration of secretions accumulated in the space between balloon 118 and the patient's trachea. When there is a negative pressure within the aspiration line 120, the aspiration line 120 can also provide additional sealing between the balloon within the patient and the wall of the trachea.

Suction line 120 can also be wrapped around balloon 118 within a predetermined sleeve on the outer surface of balloon 118. The sleeve will be further discussed in Figure 5.

In other embodiments, the aspiration line 120 can also spread the irrigation fluid when the aspiration catheter 108E is adapted to be coupled to a fluid dispensing device to dispense irrigation fluid. The rinsing fluid flows through small holes dispersed along the suction line 120.

The open distal end 122 is an opening at one end of the endotracheal tube system 100. In most embodiments, the open distal end 122 is at one end of the patient's tracheal region, and the open distal end 122 is where the air of the mechanical respirator moving through the main passage 107 can enter the patient's lungs. When the endotracheal tube system 100 is inserted into the patient, the open distal end 122 of the catheter 106 will be located within the patient's upper respiratory system. In current use, the open distal end 122 acts as a secondary source of airway for the main airway passage for mechanically breathing the patient with the open distal end 122 blocked. In the current embodiment, the open distal end 122 will still act as an airway passage.

The magnifying opening 124 provides an alternative source of airflow to the patient's lungs if the open distal end 122 is blocked or obstructed. Since the magnifying opening 124 has an opening that is significantly larger than the open distal end 122, the magnifying opening 124 acts as a primary source of airflow into the patient's lungs. The air flow from the amplification opening 124 is in contact with the inner layer of the balloon 118. The inflatable balloon 118 creates a balloon along the wall of the trachea to prevent leakage of air pressure between the patient's lungs and the tracheal tube system 100. Airflow from the enlarged opening 124 can flow around the inner layer of the balloon 118 and be redirected toward the patient's lungs. The enlarged opening 124 can have a length that is slightly longer than the length of the balloon 118 along the length of the catheter 106 such that the opening 124 can begin at a point that is approximately 360 degree sealed from the balloon 118 having the catheter 106 proximate the suction lumen outlet 116 and extends over the ball therein. The balloon 118 is near a point where the distal end 122 ends. The width of the magnification opening 124 can be adjusted to create a larger airflow cross-sectional area for circulation between the patient's lungs and the catheter 106.

In another embodiment, wherein the length of the balloon 118 can extend from near the open distal end 122 along the length of the catheter 106 and terminate near the open proximal end 104, the length of the enlarged opening 124 can be along the entire catheter 106. The length extends to provide a greater amount of airflow to allow airflow between the main channel 107 and the patient's lungs.

The amplifying air passage 126 is a passage through which fluid flows between the patient's trachea and the tracheal tube system 100. The size of the amplifying air passage 126 can be determined by taking the cross-sectional area measured by the inner diameter of the inflatable balloon 118 and subtracting the cross-sectional area of the conduit 106. The amplifying air passage 126 allows the same amount of air volume but moves into the patient's lungs at a slower speed than prior devices.

The speed at which the gas flow volume flows through the conduit may be based on an increase or decrease in conduit diameter. Reducing the input speed increases particle size, reduces fogging, and reduces micro speciation. The diameter of the pipe defines the cross-sectional area through which the air volume can flow. If the diameter of the channel increases, the velocity of the air volume flowing through the channel can be reduced. Likewise, as the diameter of the channel decreases, the same fixed volume of air is moved through the reduced diameter channel, wherein the velocity of the air volume flow must be increased to move the same fixed volume of air through the reduced diameter channel. The increased channel diameter will increase the cross-sectional area through which the air flows. The enlarged air passage 126, which is created based on the shape of the balloon 118 proximate the open distal end 122, has a larger cross-sectional area through which the air flows through the endotracheal tube system 100, and the same air volume required to expand the air passageway 126 into the lungs can be Delivered to the lungs at a reduced rate. The volume of air flowing from the enlarged opening 124 located within the balloon 118 is transmitted to the lungs through the enlarged air passage 126. Reducing the velocity of the airflow in the amplifying air passage 126 helps to resolve common causes of problems in the tracheal procedure, such as respirator-associated pneumonia (VAP). VAP can be minimized by eliminating the "atomization" of foreign matter injected into the lower region of the lung from a high velocity respirator. At present, the "atomization" of foreign matter moving into the lungs at high speed is caused by the small cross-sectional area of the conventional endotracheal tube. The smaller the cross-sectional area of the conduit, the higher the speed required to move the same air volume. The amplifying air passage 126 may allow an appropriate amount of air to flow into the patient's lungs at a reduced airflow rate, which in turn may help reduce the number of pathogens that may cause VAP to the lungs. In the embodiment, the length of the enlarged air passage 126 is 4.5 cm, and the standard Murhpy's Eye is 1.0 to 1.5 cm.

2A and 2B are diagrams similar to Fig. 1 but illustrating other embodiments of the endotracheal tube systems 200A and 200B. The tracheal catheter systems 200A and 200B, as explained in FIG. 1, may include the following elements, at least one connector 102, a catheter 106 having opposing open proximal ends 104 and an open distal end 122, a suction device 108A, a gas distribution device 108B. a fluid dispensing device 108C, a fluid reservoir 108D, at least one aspiration catheter 108E, at least one inflation catheter 110A, a guiding balloon 110B, an inflation fluid supply device 110C, at least one aspiration line 120, a plurality of amplification openings 124, at least one The air passage 126 is enlarged and at least one balloon 218A (Fig. 2A) or 218B (Fig. 2B). In other embodiments, the endotracheal tube systems 200A and 200B may not have all of the listed elements or features and/or may have other elements or features in addition to or in addition to those listed.

In addition, the endotracheal tube systems 200A and 200B may also include a vocal chord crease 202. The vocal cord recess 202 is narrow and is part of the balloon 118 that extends in an amount that requires cleaning of the patient's vocal cords. The purpose of the vocal cord recess 202 is to minimize contact between the endotracheal tube systems 200A and 200B and the patient's vocal cords. In the current embodiment, balloon 218A or 218B extends approximately the entire length of catheter 106. Balloon 218A or 218B is substantially identical to the embodiment depicted in Figure 1 except for the length of balloon 218A or 218B and the recess in balloon 218A or 218B of vocal cord recess 202. No balloon is located in the recess to avoid direct compression on the vocal cords. The recesses suspend the vocal cords by positioning the balloon on both ends of the recess, and in embodiments, the recesses are color coded so that the medical personnel can view where the recesses are located.

The plurality of magnifying openings 124 are primary airflow passages for patient breathing. The plurality of magnifying openings 124 allow the airflow velocity between the patient's lungs and the tracheal tube systems 200A and 200B to be comparable to the airflow speed that the patient will experience without the artificial assisted breathing system.

In an embodiment, the balloon 218A or 218B forms a catheter that surrounds and is attached to the catheter 106, which is open at both ends such that air can enter one end of the catheter formed by the balloon 118 and exit from the balloon 218A or 218B. The other end of the formed catheter. When one end of the endotracheal tube systems 200A and 200B is placed in the patient, air can enter the patient through both the catheter formed by the balloon 218A or 218B and the catheter 106, respectively, such that the air is compared to the absence of the balloon 218A or 218B. When present or intersected, it can enter and move into the patient through a larger cross-sectional area.

The tracheal tube systems 200A and 200B differ from each other in that portions of the balloon 218A all have the same diameter, while portions of the balloon 218B have a reduced diameter. In the embodiment, the largest portion of the balloon 218B has an outer diameter of 5 cm, and the narrowest portion has an outer diameter of 1.5 cm, and the portion between the two is simply diametrically formed to be the balloon 218B farthest from the lung. One end is reduced from 5 cm to 1.5 cm toward the end closest to the lung.

Figure 3 shows a cross-sectional view 300 taken longitudinally through the catheter along the 3-3 cut line of the catheter embodiment of Figure 1. The cross-sectional view 300 can include an outer surface 302, an inner surface 304, a wall thickness 306, a catheter 106, aspiration catheter lumen 112, an inflation catheter lumen 114, and a main channel 107.

Catheter 106, aspiration catheter lumen 112, inflation catheter lumen 114, and main channel 107 are discussed in relation to Figure 1. The outer surface 302 is the outer surface of the conduit 106. Inner surface 304 is the inner surface of conduit 106. Wall thickness 306 is the thickness of the conduit determined by outer surface 302 and inner surface 304. Wall thickness 306 may vary based on the different uses and applications of endotracheal tube system 100.

The aspiration catheter lumen 112 can be an extension of the aspiration catheter 108E (from FIG. 1), wherein the aspiration catheter lumen 112 is configured to extend along the interior of the wall thickness 306. In another embodiment, the aspiration catheter lumen 112 can be attached to extend along the outer surface 302 of the catheter 106.

The inflation catheter lumen 114 can be an extension of the inflation catheter 110A (from FIG. 1), wherein the inflation catheter lumen 114 is configured to extend along the interior of the wall thickness 306. The inflation catheter lumen 114 can be located relative to the aspiration catheter lumen 112. In another embodiment, the inflation catheter lumen 114 can be configured to extend along the outer surface 302 of the catheter 106.

Figure 4 shows a cross-sectional view 400 taken longitudinally through catheter 106 and balloon 118 along the 4-4 cut line of the embodiment of catheter 106 and balloon 118 of Figure 1. The cross-sectional view 400 can include a spinal sealant 402, an inner balloon layer 404, a balloon thickness 406, and a catheter 106. In addition, the cross-sectional view 400 can also include a main channel 107, a balloon 118, a suction line 120, and an amplifying air channel 126; all of which are further defined in FIG.

The spinal seal 402 is a point of contact along the outer surface of the catheter 106 and the inner surface of the balloon 118. The balloon inner layer 404 is the inner layer of the balloon 118. The balloon thickness 406 is the thickness of the balloon 118 when fully inflated. The balloon thickness 406 can be a variable amount depending on the enlarged air passage 126. The thicker the balloon, the smaller the enlarged air channel. Similarly, the thinner the balloon thickness 406, the larger the enlarged air passage 126. The balloon thickness 406 can be varied to provide an appropriate amount of amplified air passage 126. The spine seal 402 is designed to have no contact with the enlarged opening 124.

The spinal seal 402 connection point may extend the length of the catheter 106 (which is located inside the balloon 118) to establish a secure attachment between the balloon 118 and the catheter 106. In an embodiment, the spinal seal 402 can be opposite the enlarged opening 124 on the catheter 106 such that the enlarged opening 124 does not contact the inner wall of the balloon 118. The spinal seal 402 can be bonded to the inner wall of the balloon 118. In another embodiment, the spinal seal 402 can be infused by heat along the spine seal 402 to fuse the inner walls of the balloon 118 together. The airflow from the enlarged Murphy hole will pass through the conduit 106 through the main channel 107 and exit the conduit 106 in one of two positions: 1) at the open distal end 122 or 2) at the magnification opening 124. The air leaving the amplification opening 124 will eventually flow through the amplification air passage 126.

FIG. 5 illustrates an embodiment of a balloon assembly 500. The balloon assembly 500 can include an outer balloon layer 502, a plurality of sleeves 504, an inner balloon layer 506, a catheter connection point 508, a distal edge 510, and an inflation connection point 514.

The outer balloon layer 502 is the outer layer of the balloon 118 that is in contact with the patient's tracheal wall. For balloon-based applications, the outer balloon layer 502 is typically a rubber material having different thicknesses and elasticity. For example, the balloon 118 can be adapted for low volume, high pressure air bags or high volume, low pressure air bags. In low volume, high pressure applications, the material of the balloon can be slightly thicker and less elastic, while in high volume, low pressure applications, the material can be thinner and more elastic.

A plurality of sleeves 504 are similar channels that are disposed parallel to one another in a diagonal configuration relative to the outer balloon layer 502. The sleeve 504 is diagonally aligned in such a manner that when the outer balloon layer 502 is crimped into a cylindrical shape, the sleeve 504 will line up at the point of attachment to create a single spiral groove around the cylindrical shape of the outer balloon layer. . Once aligned with the sleeve 504, the sleeve can allow the aspiration line 120 to wrap the balloon 118 in an organized and predictable form as the suction line 120 fits neatly into the sleeve. Once the aspiration line 120 encloses the balloon 118 within the sleeve 504, the aspiration line 120 can provide fine protrusions on the surface of the balloon. Since the suction effect created by the aspiration line 120 surrounding the balloon 118 helps to securely seal the balloon to the tracheal wall, the projection provides a more stable and stable relationship between the balloon 118 and the patient's tracheal wall. seal.

The inner balloon layer 506 is the inner layer of the balloon 118. When the inner balloon layer 506 is attached to the outer balloon layer 502, it allows the balloon 118 to be shaped. Catheter connection point 508 is the portion of balloon 118 that attaches balloon 118 to the endotracheal tube. The catheter connection point 508 is the only portion of the balloon 118 that is attached to the endotracheal tube. The attachment is a tight seal of 360 degree surrounding the catheter. When the outer balloon layer 502 and the inner balloon layer 506 are attached, since the purpose of the catheter connection point 508 is to attach the balloon 118 to the endotracheal tube, the catheter connection point 508 is tightly sealed to not allow any air to circulate over the two layers. between.

Distal edge 510 is the edge of outer balloon layer 502 and inner balloon layer 506 relative to catheter connection point 508. The distal edges 510 are portions that are sealed together to create a balloon-shaped outer and inner balloon layer.

The longitudinal edge 512 is the edge that runs longitudinally along the balloon. One end of the edge is the distal edge 510 and the other end of the edge is the conduit connection point 508. The longitudinal edge 512 of the inner balloon layer 506 will be the edge that seals the opposite longitudinal edges 512 of the inner balloon layer 506 to create a cylindrical shape of the inner balloon layer 506. Likewise, the longitudinal edge 512 of the outer balloon layer 502 will be the edge that seals the opposite longitudinal edges 512 of the outer balloon layer 502 to create a cylindrical shape of the outer balloon layer 502. The outer balloon layer 502 is slightly larger than the inner balloon layer 506 such that the cylindrical shape of the outer layer can be adapted to the outer portion of the cylindrical shape of the inner layer. The sleeve 504 faces outwardly toward the outer portion of the cylindrical shape of the outer balloon layer.

Inflatable connection point 514 is where the inflation fluid of the balloon enters and exists to inflate and deflate balloon 118, respectively. The inflation connection point 514 is connected to the inflation catheter lumen 114 (Fig. 1). The inflation connection point 514 can be a hole or it can be an actual small valve connector to connect to the inflation catheter lumen 114. In other embodiments, it may only provide guidance for the indicia on the inner balloon layer to create a hole when the balloon 118 is assembled and attached to the catheter 106.

The sleeve 504 on the balloon 118 will create a passage to allow the aspiration line 120 to remain securely attached to the balloon 118. Once the balloon 118 is inflated, the aspiration line 120 is securely fitted into the helical sleeve 504 (Fig. 5) on the balloon 118. Since the slight protrusions are protrusions of the aspiration line 120, the aspiration line 120 provides fine protrusions on the surface of the balloon to provide a more stable and stable seal of the balloon with the endotracheal tube system 100 within the patient. The aspiration effect created by the aspiration line 120 surrounding the balloon 118 helps to securely seal the balloon to the tracheal wall.

The balloon 118 is formed by melting two layers of balloon layers together, wherein the outer balloon layer 502 will have a sleeve 504 to allow the suction line 120 to be located therein. One end of the balloon 118 is completely sealed to the conduit 106 proximate to the aspiration line 120. The other distal end of the balloon will not be completely sealed to the catheter 106. Instead, the inner balloon layer 506 will be attached to the spinal portion of the catheter 106 as shown by the spinal seal 402 (Fig. 4).

Figure 6A shows a flow diagram of an embodiment of a method 600A in which a caregiver intubates a patient. Initially, the caregiver determines that the patient needs an advanced oral airway, and then in step 604, the caregiver opens the patient's mouth to begin the intubation process. In step 606, the caregiver presses the patient's ankle forward to create a sufficient opening for intubation.

In step 608, the caregiver can use the laryngoscope as a guide to place the endotracheal tube above the epiglottis. The caregiver can also use an image laryngoscope to assist the intubation process. In some cases, if no guiding tools are available, the caregiver can blindly intubate if the condition requires immediate intubation. A laryngoscope is a medical device used to obtain a view of the vocal cords and glottis. Laryngoscopy (throat + microscopy) can be performed to assist intubation. The video laryngoscope is the first commercial video laryngoscope. The image laryngoscope combines a high-resolution digital camera with a video cable to connect to a high-resolution LCD display. It can be used for endotracheal intubation to provide controlled mechanical ventilation. When using a laryngoscope or an image laryngoscope to assist the cannula, the caregiver should pay special attention to discern that the vocal cord is properly inserted into the tracheal tube to prevent contact between the balloon 118 and the vocal cord. If the caregiver does not properly insert the tracheal tube under the vocal cords and if the balloon 118 is inflated onto the vocal cords, it may damage the patient's vocal cords. Additional care must be taken to ensure that the cannula is properly performed and that the vocal cords are protected from contact with the balloon even when the balloon 118 is inflated. The small aluminum needle provides a flexible endotracheal tube with some support and stiffness to aid in the intubation process.

In step 610, the caregiver properly positions the endotracheal tube in place without causing injury. Injury may include broken teeth or vocal cord damage and does not include trauma that can be expected during intubation. In step 612, the caregiver removes the small aluminum needle from the endotracheal tube once the cannula is completed.

In step 614, the caregiver inflates the balloon with air by attaching a syringe or any other fluid supply device that may be required to inflate the balloon. In some embodiments, the air can be a selected fluid. In other embodiments, a liquid system fluid can be used. When the balloon is inflated, the shape of the crimped suction line 120 fits into the sleeve on the exterior of the balloon.

The caregiver then deploys the aspiration line 120 and the balloon is inflated to the tracheal boundary.

In step 616, the caregiver connects the aspiration catheter 108E to the aspiration device 108A to provide a constant suction flow in the area adjacent the balloon and trachea above the balloon 118. The suction device can have a suction capacity adjustable knob to set the desired suction. By connecting the aspiration catheter 108E to the aspiration device 108A, the removal of secretions located above the balloon 118 and between the tracheal wall and the balloon can continue indefinitely without the caregiver constantly monitoring the patient's accumulation. Secretion.

Suction line 120 creates a seal between balloon 118 and the trachea.

In an embodiment, each step in method 600A is a separate step. In another embodiment, although described as a separate step in FIG. 6A, steps 604-616 may not be separate steps. In other embodiments, method 600A may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 600A can be performed in another order. A subset of the steps listed above as part of method 600A can be used to form its own method.

Figure 6B shows a flow diagram of an embodiment of a method 600B in which a caregiver removes an endotracheal tube. In step 652, the caregiver deflates the balloon 118 by pressing the guiding balloon 110B. In step 654, the caregiver carefully removes the endotracheal tube from the patient's mouth.

In an embodiment, each step in method 600B is a separate step. In another embodiment, although described as a separate step in FIG. 6B, steps 652-654 may not be separate steps. In other embodiments, method 600B may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 600B can be performed in another order. The subset of steps listed above as part of method 600B can be used to form its own method.

Figure 7A shows a flow diagram of an embodiment of a method 700A in which a suction device draws secretions from a region adjacent to the balloon and trachea. In step 702, the aspiration catheter 108E is coupled to the aspiration device 108A. In step 704, the negative pressure within the aspiration catheter 108E is transmitted through the aspiration catheter lumen 112 to the aspiration line 120. In step 706, a negative pressure creates a negative pressure/suction in the suction aperture of the entire aspiration line 120. In step 708, the accumulated secretions are aspirated through the suction port for processing. In step 710, a negative pressure within the aspiration line creates a seal between the balloon 118 and the patient's tracheal wall. Secretions can be collected as a sample for diagnosis for diagnosis and monitoring.

In an embodiment, each step in method 700A is a separate step. In another embodiment, although described as a separate step in FIG. 7A, steps 702-710 may not be separate steps. In other embodiments, method 700A may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 700A can be performed in another order. The subset of steps listed above as part of method 700A can be used to form its own method.

Figure 7B shows a flow diagram of an embodiment of a method 700B in which a flushing fluid dispensing device applies irrigation fluid. In step 742, the aspiration catheter 108E is coupled to the fluid dispensing device 108C. In step 744, irrigation fluid flows through aspiration catheter 108E, aspiration catheter lumen 112, and aspiration line 120. In step 746, the irrigation fluid is dispensed through a suction aperture in the aspiration line 120. The irrigation fluid allows for instantaneous interaction with the mucus and the area adjacent to the balloon and trachea. Based on the flushing fluid used, the mucus can be loosened to allow it to be easily withdrawn. In step 748, the aspiration catheter 108E is reconnected to the aspiration device 108A to remove irrigation fluid and any other secretions that may accumulate during the irrigation fluid delivery process.

In an embodiment, each step in method 700B is a separate step. In another embodiment, although described as a separate step in Figure 7B, steps 742-748 may not be separate steps. In other embodiments, method 700B may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 700B can be performed in another order. The subset of steps listed above as part of method 700B can be used to form its own method.

Figure 7C shows a flow diagram of an embodiment of a method 700C in which a mechanical respirator provides manual assisted breathing to a patient. In step 762, the endotracheal tube system 100 is coupled to the mechanical respirator via a connector 102. In step 764, the mechanical respirator is routed through the main channel 107, the enlarged opening 124, and the open distal end 122 to draw air into and out of the patient's lungs. The rate of oxygen and air flowing into the patient's lungs is reduced by the amplification opening 124 and the amplification air passage 126.

In an embodiment, each step in method 700C is a separate step. In another embodiment, although described as a separate step in Figure 7C, steps 762-764 may not be separate steps. In other embodiments, method 700C may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 700C can be performed in another order. The subset of steps listed above as part of method 700C can be used to form its own method.

FIG. 8 shows a flow diagram of an embodiment of a method 800 in which an endotracheal tube of an endotracheal tube system 100 is fabricated. In step 802, an endotracheal tube is made. In step 804, a balloon 118 is formed that involves the step of making the balloon 118. In step 806, balloon 118 is attached to the endotracheal tube from step 802. In other embodiments of method 800, step 804 can be performed prior to step 802. However, step 806 requires steps 802 and 804 to be performed sequentially to attach the endotracheal tube and balloon 118.

In an embodiment, each step in method 800 is a separate step. In another embodiment, although described as a separate step in FIG. 8, steps 802-806 may not be separate steps. In other embodiments, method 800 may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 800 can be performed in another order. The subset of steps listed above as part of method 800 can be used to form its own method.

FIG. 9 shows a flow diagram of an embodiment of a method of implementing step 802 in which the endotracheal tube system 100 is fabricated. In step 902, an endotracheal tube is fabricated that can include manufacturing the catheter 106 from a plastic (polyvinyl chloride, PVC) material in three lumens including the aspiration catheter 108E, the inflation catheter 110A, and the main channel 107. In other embodiments, other types of materials may be used to make the conduit 106, such as wire reinforced polyxylene, silicone rubber, latex rubber or stainless steel. The length, diameter, and thickness of the catheter 106 can vary based on the size of the catheter produced for different ages, genders, and sizes of the target user. Suction catheter 108E and inflation catheter 110A are constructed to form the wall of catheter 106. In other embodiments, the aspiration catheter 108E and the inflation catheter 110A can be a catheter attached to the outer surface of the catheter 106.

In step 904, a suction lumen outlet 116 is fabricated. The suction lumen outlet 116 is an outlet aperture proximate the distal end of the aspiration catheter 108E of the balloon 118. The suction lumen outlet 116 can be located slightly above a point where the balloon 118 will be attached to the catheter 106.

In step 906, the bevel cut is performed at the open distal end 122. The beveled shape of the catheter 106 facilitates the intubation process of the endotracheal tube.

In step 908, an amplification opening 124 is made. Step 908 involves cutting an elongated elliptical shaped opening proximate to the open distal end 122 on the top side of the catheter 106. The length of the enlarged opening 124 extends from the length of the catheter 106 proximate to the open distal end 122 and extends proximate to the suction lumen outlet 116.

In step 910, inflation catheter 110A, aspiration catheter 108E, and aspiration line 120 are attached to catheter 106. The inflation catheter 110A is attached to the inflation catheter lumen 114 at one end and to the guide balloon 110B at the opposite end. In another embodiment, the inflation catheter 110A can be an extension of the inflation catheter lumen 114 and a portion of step 902. In other embodiments, the guiding balloon 110B can be attached to the inflation catheter prior to insertion into the cannula.

Aspiration catheter 108E is attached to aspiration catheter lumen 112. In another embodiment, the aspiration catheter 108E can be an extension of the aspiration catheter lumen 112 and a portion of step 902.

Suction line 120 is attached to suction lumen outlet 116. Suction line 120 can be similar in material, shape, and diameter to suction conduit 108E. However, the aspiration line 120 contains a number of small holes throughout the aspiration line 120 to provide fluid transfer into and out of the aspiration line 120. In another embodiment, the aspiration line 120 can be an extension of the aspiration catheter lumen 112 and a portion of the aspiration lumen outlet 116.

A pre-formed balloon balloon can be attached to the balloon 118.

In an embodiment, each step in method 802 is a separate step. In another embodiment, although described as a separate step in Figure 9, steps 902-910 may not be separate steps. In other embodiments, method 802 may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 802 can be performed in another order. The subset of steps listed above as part of method 802 can be used to form its own method.

Figure 10 shows a flow diagram of an embodiment of a method of performing a step 804 in which a balloon is made. In step 1002, the outer balloon layer 502 is made from a flexible, rubber-like layer of a balloon typically used for endotracheal tube catheters. The outer balloon layer 502 includes a plurality of sleeves 504 disposed diagonally across the level to accommodate the passageway into which the suction line 120 is adapted when the balloon 118 is inflated. When the diagonally aligned sleeve on the outer balloon layer 502 is longitudinally crimped and attached, a helical groove for the aspiration line 120 is created. The shape of the outer layer is shown in Figure 5.

In step 1004, inner balloon layer 506 is formed using a material similar to the material used in the manufacture of outer balloon layer 502 in step 1002. The inner balloon layer 506 has the same shape as the outer balloon layer 502. The inner balloon layer 506 does not include a sleeve that is disposed across the layer facing the corners.

In step 1006, inner balloon layer 506 is crimped into a cylindrical shape and sealed along longitudinal edge 512. In step 1008, outer balloon layer 502 is crimped into a cylindrical shape and sealed along its longitudinal edge 512.

In step 1010, outer balloon layer 502 and inner balloon layer 506 are sealed to each other along distal edge 510 and balloon attachment point 508. The outer balloon layer 502 has a sleeve 504 that faces outwardly on the exterior of the attachment point. The balloon attachment point 508 is completely sealed to ensure that there is no space inflating air in the area of the connection point 508 of the balloon assembly.

In an embodiment, each step in method 804 is a separate step. In another embodiment, although described as a separate step in FIG. 10, steps 1002-1010 may not be separate steps. In other embodiments, method 804 may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 804 can be performed in another order. The subset of steps listed above as part of method 804 can be used to form its own method.

Figure 11 shows a flow diagram of an embodiment of a method of performing step 806 in which a balloon is attached to an endotracheal tube. The balloon 118 assembled in step 804 and the endotracheal tube assembled in step 802 are attached. In step 1102, the balloon 118 is attached to the endotracheal tube assembled in step 802 by inserting the distal end 122 through the balloon 118 from the attachment point 508 toward the distal edge 510. The connection point 508 is completely sealed around the conduit 106 that is adjacent to the suction lumen outlet 116 without being in contact with the suction lumen outlet 116.

In step 1104, the inner surface of the balloon 118 is sealed along the spinal seal portion 402 to the length of the spine of the catheter 106. The spinal seal portion 402 does not contact or interfere with the amplification opening 124. The inflation catheter lumen 114 is coupled to the balloon 118 at an inflation connection point 514. In step 1106, the aspiration line 120 is coiled around the catheter 106 from the suction lumen outlet 116 toward the open distal end 122. The aspiration line 120 is further guided by a helical groove created by the sleeve 504 to coil around the deflated balloon 118.

In step 1108, the aspiration line 120 is attached to the outer surface of the distal end of the balloon 118. The attachment point can be proximal to the distal edge 510 of the balloon without actually contacting the sealed distal edge 510.

In an embodiment, each step in method 806 is a separate step. In another embodiment, although described as a separate step in FIG. 11, steps 1102-1108 may not be separate steps. In other embodiments, method 806 may not have all of the above steps and/or may have other steps than those listed above in addition to or in place of those. The steps of method 806 can be performed in another order. A subset of the steps listed above as part of method 806 can be used to form its own method.

12A and 12B illustrate an alternative embodiment of an endotracheal tube system 100: an endotracheal tube system 1200. More specifically, FIG. 12A illustrates a side view of the endotracheal tube system 1200 and FIG. 12B illustrates a front view of the tracheal tube system 1200.

In the endotracheal tube system 1200, the two ends of the balloon 118 are coupled to the catheter 106, respectively, such that air or other gases do not leak out of the balloon 118. The balloon 118 includes a shaped and positioned recess 1210 to receive a portion of the aspiration line 120 disposed thereon. The recess 1210 can be positioned to correspond to the portion of the balloon 118 that is furthest from the open distal end 122 and can be sized to fit over the upper portion of the outer surface of the balloon 118 as shown in Figures 12A and 12B. The positioning of the aspiration line 120 (ie, away from the open distal end 122). For example, the recess 1210 can be sized to fit the positioning of the aspiration line 120 60°-270° (ie, 16.7%-75%) above the upper outer surface of the balloon 118.

In some embodiments, the recess 1210 can act to direct the shape of the aspiration line 120 and/or be positioned in a desired configuration, while in other embodiments, the aspiration line 120 can be, for example, a molding process, The preforming is shaped to fit within the recess 1210. For purposes of illustration, the recesses described in Figures 12A and 12B are configured to accommodate a suction line 120 shaped as follows with respect to the triangular shape described with respect to Figure 14A. However, it will be understood by those of ordinary skill in the art that the recess 1210 can be sized, shaped, and/or positioned to accommodate any number of shaped suction lines 120, as illustrated in Figure 14B, which is described in more detail below. An exemplary shaped suction line 120 of Figure 14E.

FIG. 13 illustrates an alternative embodiment of a balloon assembly 500: a balloon assembly 1300. Balloon assembly 1300 represents an exemplary balloon assembly having a recess 1210, a catheter connection point 508, a distal edge 510, and an inflation connection point 514. In some cases, the pattern of the recess 1210 can be similar to the sleeve 504 as discussed above with respect to FIG. 5 such that when the balloon 118 is assembled, the recess 1210 is positioned thereon. Additionally, the balloon assembly 1300 can be assembled to produce the balloon 118 in a manner similar to that described in FIG.

Figures 14A through 14E illustrate different exemplary configurations for the aspiration line 120. In some examples, the aspiration line 120 can be made of a rigid and/or flexible material and can be constructed in one or more pieces. Suction line 120 can be configured in any suitable shape. In some examples, the aspiration line 120 can be pre-configured to have a particular shape and/or can be assumed to be in a particular shape created by the recessed image being recessed 1210. For example, the aspiration line 120 may be configured as a triangular-like shape as shown in FIG. 14A or a curved serpentine-like shape as shown in FIG. 14B. In the embodiments of Figures 14A and 14B, the aspiration line 120 can be pre-molded to accommodate the shape of the recess 1210. The aspiration line 120 of Figures 14A and 14B can have any number of holes 1410 whereby fluid and other materials can be removed from the patient's trachea through the holes 1410 by the negative pressure applied by the aspiration line 120. . The holes 1410 can be placed in the aspiration line 120 in a uniform, clustered, and/or random pattern as may be suitable for a particular application.

In some embodiments, the aspiration line 120 can have planarized planar components having holes 1410 disposed thereon as shown in Figures 14C and 14D. Figure 14C shows the planarization planar member 1420 of the suction line 120 with the holes 1410 arranged in a random pattern, while Figure 14D shows the planarization of the suction line 120 with the holes arranged along the edges of the planarization planar member. Plane parts. The planarized planar member of Figure 14D may also include a channel or groove 1425 that may be configured and/or arranged to assist in the direction of fluid and secretions toward the aperture 1410 for application to the aspiration line 120. The negative pressure of the supplied fluid is eventually withdrawn from the trachea.

Figure 14E depicts an exemplary aspiration line 120 having a plurality of suction protrusions or suction ports 1430 configured in an exemplary triangular shape. It is noted that the suction protrusion/suction port 1430 is not drawn to scale in FIG. 14E and may be from the aspiration line 120, for example, a few microns (eg, 5 or 10 microns) to a few millimeters (eg, 0.5–5mm) extension. Suction projections/suction ports 1430 can extend from the aspiration line 120 to, for example, facilitate the application of negative pressure to the tissue, fluid, or other substance in contact.

15A and 15B illustrate an endotracheal tube system 1200 having a shaped aspiration line 120 located within a recess 1210. More specifically, Figure 15A illustrates a side view of an endotracheal tube system 1200 having a shaped aspiration line 120 located within a recess 1210, while Figure 15B illustrates a shaped aspiration line having a recess 1210. Front view of the tracheal catheter system 1200 of 120.

For purposes of illustration, Figures 15A and 15B illustrate a triangular shaped shaped suction line 120 in the recess 1210 of Figure 14A, however, it will be understood by those of ordinary skill in the art that the recess is The 1210 can be resized, shaped, and/or positioned to accommodate any number of shaped suction lines 120.

In some embodiments, the aspiration balloon 118 may not include a pre-manufactured recess 1210, and in these embodiments, the aspiration line 120 may be located on the surface of the balloon 118. In some cases, in these embodiments, the aspiration line 120 can form a recess 1210 by, for example, pressing down the portion of the inflatable balloon 118 when the endotracheal tube system 1200 or 100 is inserted into the trachea.

As described herein, positioning the aspiration line 120 on the surface of the balloon 118 can include permanently attaching the aspiration line 120 (or a portion thereof) through, for example, chemical, pressure, and/or heat generating bonds. An embodiment to the balloon 118. In other embodiments, the aspiration line 120 can be positioned on the surface of the balloon 118 by, for example, a flexible bond created by a flexible adhesive and/or lubricant. Additionally, the aspiration line 120 can be removed by simply placing the aspiration line 120 through the surface of the balloon 118 (ie, without a key, or with only a frictional key between the surface of the balloon 118 and the aspiration line 120). Positioned on the surface of the balloon 118. Additionally, the aspiration line 120 can be positioned and/or retained within the recess 1210 by a holding device such as a continuous or intermittent sleeve or clamp and/or one or more straps. In some examples, a sleeve, clamp, and/or strap may be placed on top of the positioned suction line 120 to maintain the suction line 120 in place. Additionally, in some cases, portions of the aspiration line 120 can be held in place by the airway wall in which the tracheal tube system 1200 is placed.

Suction line 120 can be located on balloon 118 such that aperture 1410 therein does not contact the surface of balloon 118. In this manner, the aperture 1410 can be directed outwardly (relative to the surface of the balloon 118) such that when inserted into the trachea, the aperture 1410 can be in contact with or nearly in contact with the tissue of the tracheal opening to aid passage through negative pressure applications. Suction line 120 draws fluid or other material from the patient's trachea.

FIGS. 16A and 16B illustrate an exemplary ablation surgical tool 1610 with ablation tip 1620 and cauterization tip 1625 and a tip end of a cystoscopy surgical tool 1615, both of which have aspiration line 120 attached thereto. . Ablation and cystoscopy surgical tools are well known in the art as tools for performing surgical procedures involving ablation or cauterization of a tip, such as ablation tip 1620 and cauterization tip 1625, which burns poor tissue (eg, a cancer or cyst). To remove bad tissue from the patient's body. Poor by-products of ablation and/or cauterization techniques are visually obstructing the production of smoke and tissue debris and fluids (eg, blood, pus, etc.) in the surgical field. Conventional methods of removing these ablation/burning byproducts involve removing the ablation/cystoscopy surgical tool from the surgical cavity such that a suction device (typically a surgical suction sleeve) can be inserted into the surgical cavity to remove Ablation/burning by-products.

However, the ablation surgical tool 1610 and the cystoscopy surgical tool 1615 have aspiration line 120 attached thereto such that when it is created, through the open or partially open end of the aperture 1410 and/or the aspiration line 120 The ablation/burning by-products can be removed from the surgical cavity by the applied negative pressure. The attachment of the aspiration line 120 to the ablation surgical tool 1610 and the cystoscopy surgical tool 1615 can act to reduce the time to perform the procedure and reduce the need for repeated insertion and removal of ablation as is conventional in ablation or cystoscopy procedures. Or cystoscopy of the surgical tool and the suction device to enter/leave the surgical cavity resulting in trauma to the tissue surrounding the surgical site. Additionally or alternatively, when ablation and cystoscopy procedures are performed by removing smoke, ash, tissue debris, and/or fluid from the surgical field continuously or nearly continuously, the aspiration line 120 and the ablation surgical tool Attachment of the 1610 and cystoscopy surgical tool 1615 can act to improve visibility.

It will be understood by those of ordinary skill in the art that various types of surgical tools (scalpels, endoscopes, micro-scissors, clamps, etc.) can benefit from the provision of aspiration lines, such as aspiration lines attached thereto. 120 is used to assist in removal from the surgical field, such as tissue, fluid, blood, and/or smoke, thereby improving visibility in the surgical field as the surgical procedure is performed.

Figure 17 shows a cross-sectional view of the endotracheal tube system 1200 positioned in the patient's trachea 1720. It should be noted that Figure 17 is not drawn to scale. In the embodiment of Figure 17, the components of the balloon 118, the recess 1210 and the aspiration line 120 are located below the patient's vocal cords 1710. The assembly can be positioned such that the aspiration line 120 or portion thereof contacts the posterior portion of the tracheal wall 1725 to extract fluid, excretion from the trachea that may otherwise accumulate or collect on the posterior wall of the trachea 1720 due to gravity applied thereto. Wait. In some examples, the components of the tracheal tube system 1200 can be preferably positioned such that the upper connection point between the balloon 118 and the catheter 106 can be located below the vocal cords 1710 (eg, 0.1 cm - 1.5 cm). Preferably, the upper attachment point is located 0.5 cm below the vocal cords 1710.

Thus, an endotracheal tube, an endotracheal tube system, and a surgical tool having a suction device attached thereto have been described. When inserting any of the endotracheal tubes described herein, a negative pressure or aspiration system (continuously, periodically, or on a desired basis) is applied from a patient by various embodiments of the various types of endotracheal tubes described herein. The collected fluids and secretions as well as pathogens and foreign bodies are extracted from the trachea. Pathogens and foreign bodies may serve as a breeding ground for bacteria and viruses and as a collection medium for aerosolized pathogens. Since the aspiration line 120 does not flow out of the lungs, the collection of fluids and secretions from the trachea can help reduce cases of VAP and other diseases.

Furthermore, since the suction and negative pressure applied by the suction line 120 are dispersed along the suction line 120 over a plurality of holes rather than being concentrated on a single hole, the use of the endotracheal tube disclosed herein can help to reduce Generally associated with the insertion of traditional tracheal catheters. Therefore, when applied to a specific tracheal position for removal of secretions and other fluids, compared to the amount of suction/negative pressure applied to only one location in the trachea (as in the case of a single suction orifice) The suction/negative pressure is relatively small. This is clinically important because the forces exerted on the tracheal tissue are spread over a larger surface area. Therefore, less force is applied at any point of the tracheal tissue, and in this manner, trauma and discomfort may be reduced due to force exerted on the tracheal tissue. This allows for longer periods of negative pressure or aspiration of the trachea without causing injury to the sensitive tracheal tissue and causing irritation and discomfort to the patient.

Additionally, embodiments of the tracheal catheter described herein can be employed within the patient's trachea regardless of the patient's orientation (eg, supine, prone, or lateral). For example, for the endotracheal tube systems 100, 200A, and 200B, the aspiration line 120 covers the entire circumference of the balloon 118, and thus, regardless of the orientation of the intubated patient or the orientation of the endotracheal tube in the patient, the tracheal wall can be applied Apply a negative pressure or suction. Moreover, for the endotracheal tube system 1200, the recess 1210 and the aspiration line 120 cover a portion of the circumference of the balloon 118 (from 60 ^o to 270 ^o ) and based on the balloon 118 covered by the recess 1210 and the aspiration line 120. The size of the portion of the circumference, regardless of the orientation of the intubated patient or the orientation of the tracheal tube when the endotracheal tube is in the patient, the aspiration line 120 can apply a negative pressure or suction to the patient's tracheal wall to withdraw the pooled liquid And other materials, a patient in the opposite direction of the endotracheal tube system 1200 is a possible exception, where in the case of gravity it will cause liquid/other substances to collect in contact with the aspiration line 120 or close enough to the aspiration line 120. Part of the tracheal wall (eg, if the patient is prone and the recess 1210 and the aspiration line 120 are oriented toward the posterior side of the patient). However, the occurrence of this exception is clinically rare, and if so, the endotracheal tube system 1200 can be positioned slightly rotated to provide a negative pressure to liquids and other materials that may collect on the anterior portion of the tracheal wall.

Moreover, once inserted into a patient by attachment to the tracheal wall, the aspiration tubing 120 of the tracheal catheter embodiment disclosed herein can be used to maintain a desired position of the endotracheal tube and thereby prevent the tracheal tube from slipping along the trachea.

Each of the embodiments disclosed herein can be used or otherwise combined with any other disclosed embodiments. Any of the elements of any of the embodiments can be used in any embodiment.

Although the present invention has been described with reference to the specific embodiments thereof, it will be understood by those of ordinary skill in the art element. In addition, modifications may be made without departing from the basic teachings of the invention.

100, 200A, 200B, 1200‧‧‧ tracheal catheter system
102‧‧‧Connector
104‧‧‧ Near end
106‧‧‧ catheter
107‧‧‧Main channel
108A‧‧‧Suction device
108B‧‧‧Gas distribution device
108C‧‧‧Fluid distribution device
108D‧‧‧ fluid reservoir
108E‧‧‧Aspiration catheter
110A‧‧‧Inflatable catheter
110B‧‧‧Guided balloon
110C‧‧‧Inflatable fluid supply device
112‧‧‧Aspiration catheter lumen
114‧‧‧Inflatable catheter lumen
116‧‧‧Sucking the lumen exit
118, 218A, 218B‧‧‧ balloon
120‧‧‧suction pipeline
122‧‧‧ distal
124‧‧‧Enlarge the opening
126‧‧‧Amplified air passage
202‧‧‧vocal depression
300, 400‧‧‧ cross-section
302‧‧‧Outer surface
304‧‧‧ inner surface
306‧‧‧ wall thickness
402‧‧‧Spine seal
404‧‧‧The inner layer of the balloon
406‧‧‧ Balloon thickness
500, 1300 ‧ ‧ balloon assembly
502‧‧‧ external balloon layer
504‧‧‧Sleeve
506‧‧‧ internal balloon layer
508‧‧‧ connection point
510‧‧‧ distal edge
512‧‧‧ longitudinal edges
600A, 600B, 700A, 700B, 700C, 800‧‧‧ methods
604, 606, 608, 610, 612, 614, 616, 652, 654, 702, 704, 706, 708, 710, 742, 744, 746, 748, 762, 764, 802, 804, 806, 902, 904, 906, 908, 910, 1002, 1004, 1006, 1008, 1010, 1102, 1104, 1106, 1108‧‧ steps
1210‧‧‧ recessed
1410‧‧‧ hole
1425‧‧‧ Groove
1430‧‧ ‧ suction port
1610‧‧‧Ablative surgical tools
1615‧‧‧Surgical tools for cystoscopy
1620‧‧‧ ablation tip
1625‧‧‧burning tip
1710‧‧‧ vocal cord
1720‧‧‧ trachea
1725‧‧‧ tracheal wall

The invention is illustrated by way of example and not limited by the drawings in the drawings

Figure 1 shows an illustration of one embodiment of an endotracheal tube.

Fig. 2A shows an illustration of an endotracheal tube similar to Fig. 1 but illustrating another embodiment.

Figure 2B shows an illustration of yet another embodiment of an endotracheal tube.

Figure 3 is a cross-sectional view taken longitudinally through the catheter along line 3-3 of the catheter embodiment of Figure 1.

Figure 4 is a cross-sectional view of the 4-4 cut line of the embodiment of the catheter and balloon of Figure 1, taken longitudinally through the catheter and balloon.

Figure 5 shows a diagram of an embodiment of a balloon assembly.

Figure 6A is a flow chart showing an embodiment of a method of inserting an endotracheal tube.

Figure 6B is a flow chart showing an embodiment of a method of removing an endotracheal tube.

Figure 7A is a flow chart showing an embodiment of a method of aspirating secretions from the cuff boundary and the tracheal region.

Figure 7B is a flow diagram showing an embodiment of a method of applying a flushing fluid to flush a fluid dispensing device.

Figure 7C is a flow chart showing an embodiment of a patient manual assisted breathing method.

Figure 8 is a flow chart showing an embodiment of a method of manufacturing an endotracheal tube.

Figure 9 is a flow chart showing an embodiment of a method of manufacturing an endotracheal tube.

Figure 10 is a flow chart showing an embodiment of a method of producing a balloon.

Figure 11 is a flow chart showing an embodiment of a method of attaching a balloon to an endotracheal tube.

Figures 12A and 12B show an embodiment of an endotracheal tube.

Figure 13 shows a diagram of an embodiment of a balloon assembly.

Figures 14A through 14E show an embodiment of a shaped suction tube.

15A and 15B show an embodiment of an endotracheal tube.

16A and 16B are diagrams showing an exemplary embodiment of a surgical tool for ablation and cystoscopy.

Figure 17 shows a cross-sectional view of the endotracheal tube system positioned in the patient's trachea.

100‧‧‧tracheal catheter system

102‧‧‧Connector

104‧‧‧ Near end

106‧‧‧ catheter

107‧‧‧Main channel

108A‧‧‧Suction device

108B‧‧‧Gas distribution device

108C‧‧‧Fluid distribution device

108D‧‧‧ fluid reservoir

108E‧‧‧Aspiration catheter

110A‧‧‧Inflatable catheter

110B‧‧‧Guided balloon

110C‧‧‧Inflatable fluid supply device

112‧‧‧Aspiration catheter lumen

114‧‧‧Inflatable catheter lumen

116‧‧‧Sucking the lumen exit

118‧‧‧ balloon

120‧‧‧suction pipeline

122‧‧‧ distal

124‧‧‧Enlarge the opening

126‧‧‧Amplified air passage

Claims (10)

An endotracheal tube system comprising: a first catheter that is flexible and hollow and has a first end and a second end; an inflatable balloon attached and circumferentially surrounding a portion of the first catheter The inflatable balloon is positioned between the first end and the second end of the first catheter, and when the inflatable balloon is inflated, includes a recess of a specific size and positioning to accommodate a second positioned therein a portion of the catheter; and the second catheter positioned within the recess, the second conduit being hollow and having a plurality of apertures along a sidewall that is not in contact with the inflatable balloon, wherein the second conduit is configured to A suction device coupled to the second conduit to generate a negative pressure. The endotracheal tube system of claim 1, wherein the second catheter is curved. The endotracheal tube system of claim 1, wherein the recess extends around a circumferential portion of the inflatable balloon. The endotracheal tube system of claim 1, wherein the first end of the first catheter is configured to be coupled to a manual assisted breathing apparatus. The endotracheal tube system of claim 1, wherein the concave portion is positioned on the inflatable balloon that coincides with a connection point between the inflatable balloon and the first catheter, the connection point is positioned Between the first end of the first catheter and the inflatable balloon. The endotracheal tube system of claim 1, wherein when the tracheal tube system is placed in an air tube, the negative pressure generated by the suction device passes through the plurality of holes in the second tube The fluid is drawn in the trachea such that the fluid is evacuated from the trachea. The endotracheal tube system of claim 1, wherein the recess and the second catheter system are positioned such that when the tracheal tube system is inserted into a trachea, the inflated balloon is inflated, and the negative pressure is by the suction When the device is applied to the second catheter, the second catheter is positioned against a portion of a tracheal wall. The endotracheal tube system of claim 1, wherein the recess and the second catheter are positioned such that when the tracheal tube system is inserted into a trachea, and the negative pressure is applied to the second by the suction device In the case of a catheter, the second catheter is positioned against a rear portion of a tracheal wall. The endotracheal tube system of claim 1, wherein the second catheter is attached to the inflatable balloon within the recess by at least one of a bond, a sleeve, a strap, and a clamp. The endotracheal tube system of claim 1, wherein the first conduit has a lumen coupled to the suction device, and a negative pressure in the lumen causes a negative pressure in the second conduit .